Drug information on dacogen decitabine includes side effects, uses, drug interactions, dosage, drug pictures, overdose symptoms, and what to avoid. Highlights of prescribing information these highlights do not include all the information needed to use effientsafely and effectively. This solution is readytouse and may be administered directly to the patient without further preparation. Each 20 ml, single dose, glass vial contains 50 mg decitabine, 68 mg 12 monobasic potassium phosphate potassium dihydrogen phosphate and 11. The summary of the opinion of the committee for orphan medicinal products for dacogen can be found on the agencys website. Dacogen decitabine for injection description e 59 66 57 70. Each 20 ml, single dose, glass vial contains 50 mg decitabine, 68 mg monobasic potassium phosphate potassium. To prepare reduced doses for patients with baseline crcl less than or equal to 60 mlmin, withdraw the. Highlights of prescribing information nss are frequent nss. Decitabine is designated an orphan drug by the fda for the treatment of mds. The resulting solution contains 10 mgml of dacarbazine having a ph of 3. While youre applying for patient assistance, use a free ps card todayjust like an instant couponto save money when you buy dacogen at your local pharmacy. Highlights of prescribing information these highlights do not include all the information needed to use entereg safely and effectively.
Results of a randomized study of 3 schedules of lowdose decitabine in higherrisk myelodysplastic syndrome and chronic myelomonocytic leukemia. The product monograph is an integral part of new drug, supplement to a new drug, abbreviated new drug and supplement to. Dacogen injection is used to treat myelodysplastic syndromes certain types of blood or bone marrow cancer dacogen may also be used for purposes not listed in this medication guide. Oct 01, 2019 if you get pregnant while taking dacogen decitabine or within 1 month after your last dose, call your doctor right away. While holding the adapter in the package, place the vial adapter over the vial and press down firmly on the package until the adapter spike penetrates the vial stopper. Dailymed dacarbazine injection, powder, for solution. Breastfeeding while receiving dacogen is not recommended. Prognostic factors associated with disease progression and.
Aseptically reconstitute dacogen with room temperature 20c to 25c 10 ml of sterile water for injection, usp. Dacogen include neutropenia, thrombocytopenia, anemia, pyrexia, fatigue, nausea, cough, petechiae, constipation, and diarrhea. List of approved products pharmaceuticals and medical. Compare prices, print coupons and get savings tips for dacogen decitabine and other myelodysplastic syndromes drugs at cvs, walgreens, and other pharmacies. Dakogen must be stored in a whole package, in a place where sunlight does not reach, moisture. Dacogen decitabine injection side effects, images, uses. Nov 01, 2014 dacarbazine for injection usp is a white to an ivory colored solid which is light sensitive. Dacogen nda accepted for filing by fda 3 january 2005 in 2005, news by webadmin. Dacogen powder for solution for injection drug summary. Fda approves dacogen decitabine for injection 3 may 2006 in 2006, news by webadmin.
Lenvima lenvatinib eisai assistance program enrollment form page 3 patient authorization for health information and disclosure i authorize my health care providers and health insurers to disclose to eisai inc. Topics az slideshows images quizzes supplements medications. Administer dacogen at a dose of 20 mgm repeat cycle every 4 weeks. Mar 06, 2020 dacogen is a cytotoxic drug and caution should be exercised when handling and preparing dacogen 1. The product is presented as a lyophilised powder, for reconstitution and further dilution prior to administration by intravenous infusion. The purpose of this guidance document is to assist sponsors in developing product monographs with acceptable format and content. Highlights of prescribing information these highlights do not include all the information needed to use dacogensafely and effectively. Print an instant ps card now, and use it as a dacogen discount card to get a cheap dacogen price.
Lenvima lenvatinib eisai assistance program enrollment. In patients taking glucophageglucophage xr whose egfr later falls below 45 mlmin1. The drug should be kept out of the reach of children. Inserting a multipaged pdf document in a lyx document. Because dacogen is a brandname drug, it can be very expensive. The temperature of storage of the preparation should not exceed 30 0. Darzalex is a prescription medicine used to treat adults with multiple myeloma. What should i discuss with my health care provider before receiving decitabine dacogen. The summary of product characteristics smpc and the package leaflet for dacogen will be updated to reflect the new information. Directions for proper use of pharmacy bulk package. Bleeding risk see full prescribing information for complete boxed warning. Prognostic factors associated with disease progression and overall survival in patients with myelodysplastic syndromes treated with decitabine. Unasyn sterile powder for intravenous use may be reconstituted with any of the compatible diluents described in this insert.
Side effects of dacogen decitabine injection, warnings, uses. In preclinical studies in mice and rats, decitabine was teratogenic, fetotoxic, and embryotoxic. Information for the user dacogen 50 mg powder for concentrate for solution for infusion decitabine read all of this leaflet carefully before you start using this medicine because it contains important information for you. Patient characteristics appearing to negatively influence os at the 0. Fda approves dacogen decitabine for injection astex. Highlights of prescribing information these highlights. Decitabine in the treatment of myelodysplastic syndromesj. Highlights of prescribing information these highlights do. Dalvance should be administered over 30 minutes by intravenous infusion see dosage and administration 2. No information is available on the pharmacokinetics of decitabine at the indicated dosage of 15 mgm. After adjustment for potential prognostic factors, the hr for treatment effect on os based on mature data was 0. Mds are a group of diseases in which the production of blood cells by the bone marrow is disrupted.
Decitabine is designed to help the bone marrow produce more healthy and normal functioning cells. Aug 19, 2019 doxil package insert pdf doxil doxorubicin hcl liposome injection is indicated for certain types of the time the drug is in the body. Pdf decitabine in the treatment of myelodysplastic syndromesj. Dacogen fda prescribing information, side effects and uses. In some cases, health care professionals may use the trade name dacogen when referring to the generic drug name decitabine. Dacogen 50 mg powder for concentrate for solution for infusion decitabine. Highlights of prescribing information adequately rehydrate. Dacarbazine for injection usp is reconstituted and administered intravenously ph 3. This strategy has already been shown to be effective in hematologic malignancies and aza and dac, have been fda approved for the treatment of myelodysplastic syndromes and acute myeloid leukemia. Mar 18, 2008 it really isnt the dacogen itself that causes the side effects, its really what dacogen does to the blood cells, severely lowering all counts which in turn affects the entire body.
Eisai inc dacogen is indicated for treatment of patients with myelodysplastic syndromes mds including previously treated and untreated. Highlights of prescribing information for intravenous. Follow applicable special handling and disposal procedures. Click the orange links and well show you extra information. Peel back the cover from the clear plastic vial adapter package. Federal usa law restricts this drug to use by or on the order of a licensed veterinarian. Each vial also contains anhydrous citric acid and mannitol. Jan 17, 2020 acetazolamide is a potent carbonic anhydrase inhibitor, effective in the control of fluid secretion e. Im certainly hoping to avoid that because of my high ferritin levels so hopefully the aranesp will continue to do the job.
Dacogen is a cancer medication that interferes with the growth and spread of cancer cells in the body. Lenvima lenvatinib eisai assistance program enrollment form page 2 physician declaration the provided information is complete and accurate to the best of my knowledge. Sanofi pasteur full prescribing information 253 daptacel. Dacogen decitabine for injection, for intravenous use fda. Solutions should be allowed to stand after dissolution to allow any foaming to dissipate in order to permit visual inspection for complete solubilization. Daptacelprimed subjects and 47% of pentacelprimed subjects and mmr vaccine. Toposar is contraindicated in patients who have demonstrated a previous hypersensitivity to it. Find medicinehuman medicinesrare disease designation. Store reconstituted product in accordance with package insert instructions store unreconstituted product at 77 degrees f. This is a pdf file of an unedited manuscript that has been accepted for publication. Fortunately, i did not take much exjade, as my ferratin was pretty low. Find medication information including related drug classes, side effects, patient statistics and answers to frequently asked questions. Warnings patients being treated with toposar must be frequently observed for myelosuppression both during and after therapy. Sections or subsections omitted from the full prescribing information are not listed.
Full prescribing information 1 indications and usage nuedexta is indicated for the treatment of pseudobulbar affect pba. Dacogen can cause fetal harm when administered to a pregnant woman. Because the number of patients with aml is low, the disease is considered rare, and. Initiation of glucophageglucophage xr in patients with an egfr between 30 45 mlminute1.
Based on its mechanism of action, dacogen alters dna synthesis and is expected to result in adverse reproductive effects see clinical pharmacology 12. An application for marketing authorisation was also submitted to the in 2005, but ema subsequently withdrawn. Highlights of prescribing information these highlights do not. What is the most important information i should know about decitabine dacogen. Dacogen decitabine for injection description e 59 66. Dacogen, inndecitabine european medicines agency europa eu.
Dacogen decitabine forinjection, for intravenous use initial u. The drug was given as three 1h infusions, separated by. Dacogen has been approved in the 2006 for the treatment of usa since odysplastic may myel syndrome. Do not save any unused portions for later administration. Multivariate and subgroup analyses of a randomized. Lenvima lenvatinib eisai assistance program enrollment form. Discard unused portions of each vial properly see how suppliedstorage and handling 16. Kantarjian h, oki y, garciamanero g, huang x, obrien s, cortes j, faderl s, buesoramos c, ravandi f, estrov z, et al. View the prescribing information for cubicin daptomycin for injection and cubicin rf daptomycin for injection below.
It is used in patients who are not eligible for standard induction chemotherapy initial treatment with cancer medicines. A phase i trial and pharmacokinetic study of 5aza2deoxycytidine 5azadcyd were conducted in 21 patients with advanced solid tumors. As a service to our customers we are providing this early version of the manuscript. Dacogen decitabine dose, indications, adverse effects. What are the possible side effects of decitabine dacogen. Dacogen decitabine for injection is supplied as a sterile, lyophilized white to almost white powder, in a singledose vial, packaged in cartons of 1 vial. Mar 01, 2020 dacogen can cause fetal harm when administered to a pregnant woman. Upon receipt, store refrigerated at 2c to 8c 36f to 46f. May 27, 2011 ive had two four cycle treatments of dacogen. Do not use if there is evidence of particulate matter or discoloration. These highlights do not include all the information needed to use advate safely and effectively. Treatment with tricor should be initiated at a dose of 48 mg per day in patients having mild to moderately impaired renal function, and increased only after evaluation of the effects on renal function and lipid levels at this dose. Dacogen is a nucleoside metabolic inhibitor indicated for treatment of patients with myelodysplastic syndromes mds.
The calculated dose of the resulting solution is drawn into a. It is given as an infusion into a vein over a period of time. Decitibine is an anticancer antineoplastic or cytotoxic chemotherapy drug. The use of tricor should be avoided in patients with. Dacogen decitabine for injection description dacogen decitabine for injection contains decitabine 5aza2deoxycytidine, an analogue of the natural nucleoside 2deoxycytidine. Dacogen decitabine 50 mg, powder for concentrate for solution.
Pba occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by. Decitabine is a cytosine nucleoside analogue which inhibits dna methyltransferase and is intended for the treatment of acute myeloid leukaemia aml. An application for marketing authorisation was also submitted to the in 2005, but ema. Each 20 ml vial contains 200 mg of dacarbazine, usp active ingredient. Upon reconstitution, the final concentration of the reconstituted dacogen solution is 5 mgml. The recommended dosage regimen of dalvance in patients with normal renal function is 1500 mg, administered either as a single dose, or mg followed one week later by 500 mg. For specific pages follow the instructions as also given in the template dialog box of the pdfpages template in the file tab of the lyx. Prevnar is stable at temperatures up to 25c 77f for 4 days.
The nda for dacogen decitabine injection was submitted to the fda on nov. This strategy has already been shown to be effective in hematologic malignancies and aza and dac, have been fda approved for the treatment of. Shinkasumigaseki building, 332 kasumigaseki, chiyodaku, tokyo 0 japan. Dacogen is indicated for treatment of adult patients with myelodysplastic syndromes. Doselimiting bone marrow suppression is the most significant toxicity associated with etoposide therapy. Dacarbazine for injection 200 mgvial is reconstituted with 19. In combination with the medicines lenalidomide and dexamethasone in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells autologous stem cell transplant and in people who have received at least one.
Decitabine dacogen mds myelodysplasia chemoexperts. Mgi pharma and supergen have announced that the new drug application nda for dacogen for injection was accepted for filing by the fda. Prescribing information cubicin daptomycin for injection. Dacogen is used to treat adults with newly diagnosed acute myeloid leukaemia aml, a type of cancer affecting the white blood cells. A package insert is required by the fda and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. This medication is classified as an antimetabolite and a demethylation agent. Ndc 6285660001, 50 mg singledose vial individually packaged in a carton. He did say that eventually i may need transfusions. In combination with the medicines lenalidomide and dexamethasone in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells autologous stem cell transplant and in people who have received at least one prior medicine to treat multiple myeloma. Our dacogen decitabine for injection side effects drug center provides a comprehensive view of available drug information on the potential side effects when taking this. Dacogen 50mg powder for concentrate for solution for infusion. Discontinue glucophageglucophage xr if the patients egfr later falls below.
It is recommended that patients be treated with dacogen for a minimum of four cycles, and treatment may continue as long as. Long story why i was asking about vidaza and dacogen but the good news is that i dont need it. Start allopurinol or xanthine oxidase inhibitor 23 days prior to initiation of venclexta venetoclax tablets. Home 1 2005 2 dacogen nda accepted for filing by fda. Read all of this leaflet carefully before you start using this medicine because it. It is unknown if this drug passes into breast milk or if it could harm a nursing baby.